Pharma Focus Asia

QIAGEN Enhances Syndromic Testing in Malaysia with MDA Approval of Advanced QIAstat-Dx Respiratory Panel

Tuesday, June 04, 2024

QIAGEN has introduced an improved version of its QIAstat-Dx Respiratory SARS-CoV-2 Panel in Malaysia, following approval by the Medical Device Authority (MDA). This new version, which holds a CE-IVD mark, increases its detection capability from 22 to 23 pathogens and is compatible with the QIAstat-Dx Rise system, a high-capacity variant of the QIAstat-Dx automated syndromic system.

Influenza-like illnesses can be caused by a variety of bacterial and viral pathogens, leading to overlapping symptoms. According to the World Health Organization (WHO), Malaysia recorded around 19,000 deaths from respiratory infections last year. The prevalence of these infections often spikes during the monsoon season due to the creation of ideal bacterial breeding grounds by stagnant water. The new QIAstat-Dx Respiratory SARS-CoV-2 Panel is a crucial tool for addressing these health challenges, particularly during such critical weather periods.

This upgraded panel is a multiplexed nucleic acid real-time PCR test designed for the qualitative detection of common pathogens presenting with influenza-like symptoms. It now can detect and differentiate among 23 viral and bacterial targets, including Chlamydophila pneumoniae.

QIAGEN, stated, "We are excited to announce the launch of our enhanced QIAstat-Dx Respiratory SARS-CoV-2 Panel in Malaysia. This panel is invaluable for emergency physicians to accurately diagnose patients in the emergency department. The results enhance our understanding of the patient’s disease progression and help us develop optimal treatment plans."

The QIAstat-Dx system, intended for laboratory use, utilizes cost-efficient, single-use cartridges with built-in sample processing and on-board reagents. By employing multiplex real-time PCR, it can detect and differentiate multiple pathogens, delivering results in about an hour. This rapid and accurate testing allows healthcare providers to make informed clinical decisions swiftly, facilitating timely therapeutic interventions, especially crucial for managing upper respiratory tract infections (URTIs).

The QIAstat-Dx system integrates with the QIAsphere cloud-based platform, enabling remote monitoring of instruments and test status. This platform allows users to receive push notifications on personal devices and monitor an unlimited number of instruments across various hospitals or satellite labs, reducing downtime and enabling quick and accurate syndromic testing.

According to the QIAsphere Insights dashboard, there was greater pathogen diversity in respiratory illnesses in 2023. SARS-CoV-2 constituted fewer than 10% of positive detections, while Rhinovirus/Enterovirus was the most prevalent at 34.2%. There was also an increase in bacterial detections, including L. pneumophila (0.1%), M. pneumoniae (0.8%), and B. pertussis (0.9%). Reviewing historical respiratory pathogen positivity rates in a lab or hospital can help understand recurring infections and pathogen diversity, allowing for precise antibiotic treatments.

QIAstat-Dx solutions and syndromic tests are available in over 100 countries globally. The systems have been installed in various hospitals, including those under the Malaysian Ministry of Health, with the first installation in 2019. QIAstat-Dx is available in two formats: the QIAstat-Dx Analyzer, which integrates up to four Analytical Modules, and the higher-capacity QIAstat-Dx Rise, which can conduct up to 160 tests per day using eight Analytical Modules.



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